HealthyPhase 1NCT01497483
Drug-Drug Interaction Study With Pravastatin and Cyclosporine
A Phase 1 study testing Pravastatin alone and Pravastatin and Cyclosporine in people with Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will address the following question: Does cyclosporine affect the pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the organic anion transporter required for pravastatin transport into the liver, thus increasing pravastatin levels in the blood. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pravastatin alone and Pravastatin and Cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Carrier of one of the three SLCO1B1 polymorphisms that we are studying (SLCO1B1 521TT, 521TC, 521CC)
- Men or women (women must have negative pregnancy test)
- ages 18 to 45 years
- Caucasian
- Healthy, including no renal or hepatic disease, as determined from plasma creatinine and liver enzyme levels
- No medications currently, except for vitamins and oral contraceptive pills
- Willingness to spend two nights at the San Francisco General Hospital
- Sign informed consent
Who cannot join
- Under 18 years old
- Unable to confirm Caucasian ancestry
- Pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit)
- Prior history of allergic reaction to pravastatin or cyclosporine
- Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
- Has prior renal or hepatic dysfunction
Show all 12Show fewer
- Risk of urinary or gastric retention or narrow-angle glaucoma (by medical history examination)
- Impaired renal function (e.g. as suggested by abnormal creatinine clearance, eGFR < 60 or serum creatinine > 1.4 mg/dl in females and > 1.5 mg/dl in males) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction (heart attack), and septicemia, abnormal heart rhythms (tachyarrhythmias; heart beat > 100 beats per minute)
- Impaired hepatic function (> 1.5 times the upper limit of normal)
- Evidence of anemia (hemoglobin <10g)
- Taking medications other than vitamins that could confound study results
- They do not provide informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hosptail
San Francisco, California, 94110
About this study
Official title: The Pharmacokinetic Interaction Between Pravastatin and Cyclosporine in Healthy Volunteers
This study will address the following question: Does cyclosporine affect the pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the organic anion transporter required for pravastatin transport into the liver, thus increasing pravastatin levels in the blood. The investigators hypothesize that this inhibition will vary among people based on genetic differences. This knowledge is important to help develop safer and more effective drug therapy with reduced side effects.
Read the detailed description
Screening Procedures:
Prior to enrollment, subjects will be asked to come to the Clinical and Translational Science (CTSI) Clinical Research Center (CRC) at San Francisco General Hospital (SFGH). The study protocol and procedures will be explained in detail, all questions will be answered, and subjects will be provided with a consent form to sign. The screening visit will be conducted within 14 days of the first inpatient visit (i.e. first pravastatin with placebo or pravastatin with cyclosporine dosing day)
Only after subjects have consented to participate in the study will the screening procedures commence. During the screening visit, vital signs as well as blood sample (10 mL) will be taken by venipuncture to measure a complete blood count (CBC), electrolytes, blood urea nitrogen (BUN), creatinine, and liver function tests (LFTs) to screen for anemia and renal or hepatic insufficiency (see Inclusion/Exclusion Criteria)
Procedures During Main Study:
An equal number of subjects will be randomized, by a computer program, into one of the two study arms described below. On the first day of the study, subjects will be dosed with either 100 mg cyclosporine or placebo at 8PM, followed by an overnight fast. On the morning of Day 2, subjects will be asked to take a second dose of 100 mg cyclosporine or placebo at 8AM. At 9AM of Day 2, subjects will be asked to take 40 mg pravastatin. Plasma samples (5 ml) will be collected at baseline (prior to pravastatin administration), then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 hours post-dose. Whole blood will also be collected 12 hours post-dose to measure the cyclosporine level.
The procedures during the second visit of the study will be identical to the first, but with dosing of 100 mg cyclosporine or placebo, opposite of what was dosed at the first study visit.
Clinical and Laboratory Determinations:
Analytical Methods:
Measurement of pravastatin in plasma will be performed by High Performance Liquid Chromatography (HPLC) with tandem mass spectrometry (MS/MS), using assays previously described and validated.
- Conditions
- Healthy
- Being tested
- Pravastatin alone, Pravastatin and Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin aloneDrug
Pravastatin 40 mg with placebo.
Pravastatin and CyclosporineDrug
Pravastatin 40 mg co-administered with 200 mg of cyclosporine.
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin alone | Active comparator | Subjects will be dosed with Pravastatin alone (40 mg) Receives: Drug: Pravastatin alone |
| Pravastatin and Cyclosporine | Experimental | Subjects will be dosed with pravastatin and cyclosporine. Receives: Drug: Pravastatin and Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics of co-administration of pravastatin & cyclosporine in healthy volunteers
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Deanna Kroetz, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497483
- Sponsor's protocol ID
- 11-06315
- Other IDs
- U01GM061390
- Status last verified
- Jan 2015
- First submitted
- 7 Dec 2011
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic Interaction Between Pravastatin and Cyclosporine in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01497483
- Acronym / sponsor ID
- 11-06315
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will address the following question: Does cyclosporine affect the pharmacokinetics of pravastatin in healthy volunteers? Studies have shown that cyclosporine inhibits the organic anion transporter required for pravastatin transport into the liver, thus increasing pravastatin levels in the blood. The investigators hypothesize that this inhibition will vary among people based on genetic differences. This knowledge is important to help develop safer and more effective drug therapy with reduced side effects.
Detailed description
Screening Procedures:
Prior to enrollment, subjects will be asked to come to the Clinical and Translational Science (CTSI) Clinical Research Center (CRC) at San Francisco General Hospital (SFGH). The study protocol and procedures will be explained in detail, all questions will be answered, and subjects will be provided with a consent form to sign. The screening visit will be conducted within 14 days of the first inpatient visit (i.e. first pravastatin with placebo or pravastatin with cyclosporine dosing day)
Only after subjects have consented to participate in the study will the screening procedures commence. During the screening visit, vital signs as well as blood sample (10 mL) will be taken by venipuncture to measure a complete blood count (CBC), electrolytes, blood urea nitrogen (BUN), creatinine, and liver function tests (LFTs) to screen for anemia and renal or hepatic insufficiency (see Inclusion/Exclusion Criteria)
Procedures During Main Study:
An equal number of subjects will be randomized, by a computer program, into one of the two study arms described below. On the first day of the study, subjects will be dosed with either 100 mg cyclosporine or placebo at 8PM, followed by an overnight fast. On the morning of Day 2, subjects will be asked to take a second dose of 100 mg cyclosporine or placebo at 8AM. At 9AM of Day 2, subjects will be asked to take 40 mg pravastatin. Plasma samples (5 ml) will be collected at baseline (prior to pravastatin administration), then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 hours post-dose. Whole blood will also be collected 12 hours post-dose to measure the cyclosporine level.
The procedures during the second visit of the study will be identical to the first, but with dosing of 100 mg cyclosporine or placebo, opposite of what was dosed at the first study visit.
Clinical and Laboratory Determinations:
Analytical Methods:
Measurement of pravastatin in plasma will be performed by High Performance Liquid Chromatography (HPLC) with tandem mass spectrometry (MS/MS), using assays previously described and validated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin alone | Active comparator | Drug: Pravastatin aloneSubjects will be dosed with Pravastatin alone (40 mg) |
| Pravastatin and Cyclosporine | Experimental | Drug: Pravastatin and CyclosporineSubjects will be dosed with pravastatin and cyclosporine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Carrier of one of the three SLCO1B1 polymorphisms that we are studying (SLCO1B1 521TT, 521TC, 521CC)
- Men or women (women must have negative pregnancy test)
- ages 18 to 45 years
- Caucasian
- Healthy, including no renal or hepatic disease, as determined from plasma creatinine and liver enzyme levels
Key exclusion criteria (12 listed)
- Under 18 years old
- Unable to confirm Caucasian ancestry
- Pregnant or lactating women (female subjects will have a urine pregnancy test at the screening visit)
- Prior history of allergic reaction to pravastatin or cyclosporine
- Has a risk of congestive heart failure requiring pharmacologic treatment (medical history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin alonePravastatin 40 mg with placebo. | Drug | Pravastatin alone |
| Pravastatin and CyclosporinePravastatin 40 mg co-administered with 200 mg of cyclosporine. | Drug | Pravastatin and Cyclosporine |
Primary outcome
Composite of Pharmacokinetics of co-administration of pravastatin & cyclosporine in healthy volunteers
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deanna Kroetz, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pravastatin alone and Pravastatin and Cyclosporine in people with Healthy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Pharmacokinetics of co-administration of pravastatin & cyclosporine in healthy volunteers (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.